Qbrexza (Topical application)

Generic name: glycopyrronium tosylate (glye-koe-pir-OH-nee-um TOS-i-late) (Topical application route)
Drug class: Miscellaneous topical agents

Commonly used brand name(s)

In the U.S.

• Qbrexza

Available Dosage Forms:

• Pad

Therapeutic Class: Cholinergic Antagonist

Pharmacologic Class: Antimuscarinic

Uses for Qbrexza

Glycopyrronium tosylate is used to treat excessive underarm sweating (primary axillary hyperhidrosis).

This medicine is available only with your doctor's prescription.

Before using Qbrexza

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of glycopyrronium tosylate in children younger than 9 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glycopyrronium tosylate in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bladder problems (eg, distended bladder, bladder-neck obstruction) or
• Enlarged prostate or
• Trouble passing urine—Use with caution. May make these conditions worse.

• Blood or vessel disease in acute bleeding, unstable or
• Glaucoma or
• Myasthenia gravis (nerve or muscle disease) or
• Sjogren's syndrome (immune system disorder) or
• Stomach or bowel problems (eg, paralytic ileus, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis)—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper use of Qbrexza

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Apply this medicine to clean, dry skin on your underarm areas only. Do not get it into your eyes, nose, or mouth. Do not swallow the medicine or apply over broken skin.

To use the cloth:

• Wash your hands with soap and water before and after you use this medicine.
• Tear open the pouch and pull out the cloth.
• Unfold the cloth and wipe across one underarm one time. Use the same cloth and wipe across the other underarm one time.
• Do not cover the treated area with a bandage unless your doctor has told you to.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cloth):
  • For excessive sweating of the underarms:
    • Adults and children 9 years of age and older—Apply 1 cloth to both underarm areas once every 24 hours.
    • Children younger than 9 years of age—Use and dose must be determined by your doctor.

Missed dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep this medicine away from heat or flame.

Precautions while using Qbrexza

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not use this medicine to treat a skin problem your doctor has not examined.

Check with your doctor right away if you or your child have a decrease in urine volume, a decrease in the frequency of urination, difficulty in passing urine, or painful urination.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. Avoid places that are very hot. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

This medicine may cause blurred vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Qbrexza side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Blurred vision
• trouble in urinating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bigger, dilated, or enlarged pupils (black part of the eye)
• dry mouth
• fever
• headache
• increased sensitivity of the eyes to light
• muscle aches
• pain in the mouth or throat
• redness, burning, stinging, or itching of the skin
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Less common

• Constipation
• dry eye
• dry skin
• dry throat
• nasal dryness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.